Device product
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.
Z-2005-2020
Product summary
- Firm
- Genicon, Inc.
- Event
- Event 85403
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1550
- Official record key
device-enforcement:Z-2005-2020
Official wording
Reason: Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Code information: Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
Derived failure modes
-
Unknown
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.